Long-term rituximab safe, effective in primary Sjögren syndrome

Treatment with rituximab (RTX) in the long term is safe and well tolerated in patients with primary Sjögren syndrome (pSS), claims a recent study. In addition, long-term RTX demonstrates effectiveness in significantly reducing European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) values and controlling disease activity.

A team of investigators performed a historical cohort study, including 35 patients with pSS treated with RTX between 2008 and 2019 in a single rheumatologic unit. Treatment was suspended when adverse events occurred. Patient data were also recorded.

Most of the patients (mean age 54 years) were female (91 percent). Twelve patients (37.1 percent) suspended treatment (10 cases per 100 patient-years, 95 percent confidence interval, 0.06‒0.17). Baseline demographics, disease characteristics, ESSDAI values, and treatment were similar across RTX-suspended and nonsuspended cohorts.

The investigators followed patients exposed to RTX for 35.82 months, with time of observation varying from 6 to 96 months. All patients, except for one, had a significant and meaningful improvement in ESSDAI (≥3 points) during the long-term follow-up.

Thirteen patients (37 percent) ceased treatment with RTX during follow-up. Four of them (30.8 percent) stopped treatment following the first administration due to infusion-related reactions. For subsequent courses of RTX, seven patients had hypogammaglobulinemia onset which resulted in treatment withdrawal; two of them experienced hypogammaglobulinemia associated with severe infections.